UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trials for the safety and efficacy of the combination of XELOX,the colorectal cancer radical resection adjuvant chemotherapy and of chronic hepatitis therapeutic agent 3 oxygelmillpropionic acid polymer.(Phase 1 test)
Acronym	Seroshion test (adjuvant chemotherapy)
Scientific Title	Clinical trials for the safety and efficacy of the combination of XELOX,the colorectal cancer radical resection adjuvant chemotherapy and of chronic hepatitis therapeutic agent 3 oxygelmillpropionic acid polymer.(Phase 1 test)
Scientific Title:Acronym	Seroshion test (adjuvant chemotherapy)
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	the aim is to evaluate the safety of 3-oxygelmill propionic acid polymer in combination with the adjuvant chemotherapy,XELOX for the radical surgery patients in the colorectal cancer cases.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The dose of Seroshion is 1 capsule (10mg) after each meal,three times a day.We start the Seroshion administration at the first day of the chemotherapy,and also continue to intake it ,if you don't continue the chemotherapy. The end of chemotherapy is the end of Seroshion.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients diagnosed histologically colorectal cancer. 2)Curative resection,R0 was performed. 3)Patients are diagnosed pathological Stage3 at the postoperative time. 4)20 years older. 5)PS is 0 or 1. 6)Patients who don't receive the treatment except surgery. 7)Oral ingestion is possible. 8)Major organ function is checked by the clinical examination within 14 days. 9) Patients who can receive the treatment within postoperative 8 weeks. 10)The written consent is obtained.
Key exclusion criteria	1) Patients who could not resect curatively. 2) Patients with active double cancer. 3) Patients with severe drug hypersensitivity, or with a history of drug allergy. 4) Patients with serious complications (heart failure, renal failure, liver failure, bleeding ulcer, watery diarrhea, intestinal paralysis, intestinal obstruction, severe diabetes). 5)Patients of cirrhosis with jaundice or of suspected cirrhosis of the liver. 6)Patients with the history of chronic hepatitis B and with the experience of Seroshion. 7)Patients with active infection. 8)Women with the possibility of pregnancy,during pregnancy,with the hope of pregnancy,or with breast-feeding. 9)Patients with mental severe disorder. 10)Other cases who doctor determines that patients are unsuitable for safely carrying out the present study.
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mizushima Tsunekazu
Organization	Osaka University,Graduate School of Medicine
Division name	Gastroenterological Surgery
Zip code
Address	2-2,Yamadaoka,Suita City, Osaka
TEL	0668793251
Email	tmizushima@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Mizushima Tsunekazu
Organization	Osaka University,Graduate School of Medicine
Division name	Gastroenterological Surgery
Zip code
Address	2-2,Yamadaoka,Suita City, Osaka
TEL	0668793251
Homepage URL
Email	tmizushima@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Hospital
Institute
Department

Funding Source
Organization	Self finding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date	2016 Year 05 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 05 Month 24 Day
Last modified on	2021 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025705